A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Combination Treatment of Fimasartan/Atorvastatin in Patients With Essential Hypertension and Dyslipidemia
Overview
- Phase
- Phase 3
- Intervention
- Placebo for Fimasartan 120mg
- Conditions
- Essential Hypertension, Dyslipidemia
- Sponsor
- Boryung Pharmaceutical Co., Ltd
- Enrollment
- 133
- Locations
- 1
- Primary Endpoint
- LDL-C
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The objective of this clinical study is to evaluate the efficacy and safety by comparing the fimasartan/atorvastatin treatment group to the fimasartan/placebo treatment group and the placebo/atorvastatin treatment group respectively at Week 8 in patients with essential hypertension and dyslipidemia.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Voluntarily provided a written consent to participate in this clinical study
- •Male or female adults aged 19-70 years
- •Patients must have been confirmed essential hypertension and dyslipidemia at Screening visit (V1)
- •Uncontrolled blood pressure (140 mmHg ≤ mean SiSBP \< 180 mmHg) at the pre- baseline visit (V2) after wash-out period
- •Able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion
Exclusion Criteria
- •Severe hypertension with mean Sitting systolic blood pressure(SiSBP)≥180 mmHg or Sitting diastolic blood pressure(SiDBP) ≥110 mmHg at the screening visit (V1) and the pre-baseline visit (V2), or orthostatic hypotension accompanied by symptoms
- •Difference of Sitting systolic blood pressure(SiSBP) ≥ 20 mmHg and Sitting diastolic blood pressure(SiDBP) ≥ 10 mmHg between Lt and Rt arms for 3 consecutive times at the screening visit (V1)
- •Secondary hypertension patients: Secondary hypertension is not limited to the following diseases; (e.g., renovascular disease, adrenal medullary and cortical hyperfunctions, coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's syndrome, pheochromocytoma, and polycystic kidney disease)
- •Uncontrolled diabetes mellitus (currently on insulin, or HbA1c \>9% at the pre-baseline visit (V2)), or uncontrolled hypothyroidism (TSH ≥1.5 times the upper limit at the pre-baseline visit (V2))
- •Heart disease (heart failure of New York Heart Association (NYHA) class 3 and 4), or ischemic heart disease (angina pectoris, myocardial infarction), peripheral vascular diseasenewly diagnosed within 6 months prior to the screening visit (V1), percutaneous transluminal coronary angioplasty, or coronary artery bypass graft, etc.
- •Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter; or other arrhythmia conditions that are determined to be clinically significant by the investigator
- •Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, or hemodynamically significant aortic valve stenosis or mitral valve stenosis
- •Cerebrovascular disorder (stroke, cerebral infarction, transient cerebral ischemic attack, cerebral hemorrhage, etc. within 6 months prior to the screening visit (V1)
- •Pregnant or lactating women
Arms & Interventions
Active Comparator 2
Co-administration of Atorvastatin 40mg and Placebo for Fimasartan 120mg
Intervention: Placebo for Fimasartan 120mg
Experimental
Co-administration of a fixed dose combination of Fimasartan 120mg and Atorvastatin 40mg
Intervention: Fimasartan 120mg
Experimental
Co-administration of a fixed dose combination of Fimasartan 120mg and Atorvastatin 40mg
Intervention: Atorvastatin 40mg
Active Comparator 1
Co-administration of Fimasartan 120mg and Placebo for Atorvastatin 40mg
Intervention: Fimasartan 120mg
Active Comparator 1
Co-administration of Fimasartan 120mg and Placebo for Atorvastatin 40mg
Intervention: Placebo for Atorvastatin 40mg
Active Comparator 2
Co-administration of Atorvastatin 40mg and Placebo for Fimasartan 120mg
Intervention: Atorvastatin 40mg
Outcomes
Primary Outcomes
LDL-C
Time Frame: 8weeks from Baseline Visit
The change in LDL-C from baseline in the test group at Week 8 compared to the active comparator group 1(fimasartan 120 mg)
SiSBP
Time Frame: 8weeks from Baseline Visit
The change in Sitting systolic blood pressure(SiSBP) from baseline in the test group(Fimasartan 120mg/Atorvastatin 40mg) at Week 8 compared to the Active Comparator group 2(Atorvastatin 40mg)
Secondary Outcomes
- LDL-C(8weeks from Baseline Visit)
- SiSBP(8weeks from Baseline Visit)